Kornimate/medical-research-clean huggingface dataset:
silent ureteral stone: impact on renal function and kidney anatomy

Conditions: Urinary Calculi

Summary: ureteral stones may be silent in 5.3% of patients. the goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function.

the prevalence of nephrolithiasis is increasing worldwide, reaching 5.2% in north america and 10.1% in italy. the widespread use of computed tomography and ultrasonography have resulted in a greater detection rate of asymptomatic stones and, in part, might explain the trend. clinically, kidney or ureteral stones range in severity from asymptomatic to presenting with complete renal failure. therefore, it is not only the alarming incidence of urinary stone disease, but also the associated burden that makes this one of the most concerning conditions in public health. the situation becomes even more distressing when managing asymptomatic stones. studies of the natural history of stones have revealed that only 20% of patients yearly actually become symptomatic from a new stone, and one half of those require surgical intervention at some point. the guidelines are well established for the treatment of symptomatic urolithiasis, and many investigators have extensively studied the management of silent kidney stones. conversely, the same is not true for silent ureterolithiasis. the purpose of the present study is to report the investigators experience managing silent ureteral stones and to prospectively analyze their true influence on renal function.

Eligibility criteria:
inclusion criteria: * silent ureteral stone: no subjective/objective symptoms related to the ureteral calculi. * patient willing to participate in the study * complete pre/post-operative work-up exclusion criteria: * treatment outside our institution * no will to be a part of the study * incomplete pre/post-operative work-up

Keywords: asymptomatic ureteral calculi renal function treatment
pilot-testing the effect of magnetic mitohormesis therapy for treating frailty in older adults

Conditions: Frailty

Summary: thirty (30) adults with limited physical function will be recruited to participate in a double-blind pilot randomized controlled crossover trial in which all participants will receive 12-weeks of twice weekly mmt treatment in the first (phase 1) or second half (phase 2) of the study period; during the control period, participants will receive sham treatment and will be blinded to the randomization.


Eligibility criteria:
inclusion criteria: * physical frailty or pre-frailty, indicated by short physical performance battery score \<10; * intact cognition indicated by a mini-cog screening test score \> 2; * able to read and write in english; and * access to a telephone. exclusion criteria: * active malignancy; * neuro-degenerative disease * active electronic implants; * any health conditions that would prevent performing the testing and intervention procedures; * major surgical procedures within the last 6 months; * major change in prescription medications within the last 3 months

Keywords: frailty aging physical performance
a clinical study to evaluate efficacy and safety of a cosmetic product in the treatment of facial lines

Conditions: Fine Lines; Wrinkles; Photoaging

Summary: this randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. a total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

this randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face. efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. self-assessment questionnaires and visia photography will be completed at baseline, weeks 4, 8, and 12. 3d primos photography will be performed at baseline, weeks 8 and 12. a total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Eligibility criteria:
inclusion criteria: * women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site. * women with fitzpatrick skin type i-vi * subjects must have mild to moderate global face wrinkles and fine lines * subjects may have mild to moderate photo-aging secondary to physiologic aging * subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation. * subjects must be willing to provide verbal understanding and written informed consent. exclusion criteria: * female subjects who are pregnant, breast feeding, or planning a pregnancy. * subjects with severe overall photo damage as determined by the investigator. * subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin. * subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. * subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the investigator. * subjects who spend excessive time out in the sun. * subjects who are unwilling or unable to comply with the requirements of the protocol.

Keywords: anti-aging serum
iti using sct800 alone or combining daratumumab in hemophilia a adolescents and adults with high titer inhibitor

Conditions: Hemophilia A With Inhibitor

Summary: to evaluate the time of response, sustained remission rate, and relapse rate of cd38 monoclonal antibody (daratumumab) combined with sct800 (rfviii) in the treatment of hemophilia a adolescents and adults with high titer inhibitors.

this is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- sct800 combined with daratumumab or sct800 alone in hemophilia a adolescents and adults with high titer inhibitors. patients will receive daratumumab combined with sct800 or sct800 alone.

Eligibility criteria:
inclusion criteria 1. moderate or severe hemophilia a; 2. aged 14-66 years old; 3. inhibitor positive at 2 consecutive visits; 4. inhibitor titer \> 10 bu at the screening visit. exclusion criteria: 1. the patient has contraindications to drug ingredients or hamster protein allergy; 2. suffering from other immune diseases or using immunosuppressant is to treat another disease(s); 3. failed systemic iti treatment in history; 4. poor patients compliance; 5. the investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.
to evaluate the efficacy and safety of huc3-053 in patients with dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: this is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of huc3-053 in patients with dry eye syndrome. after a 2-week run-in period, patients will be randomized equally to the huc3-053 or hyalein mini drops administered bilaterally five to six times a day for 12 weeks.

this is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of huc3-053 in patients with dry eye syndrome. during a 2-week study run-in period prior to randomization, all subjects will receive rescue drug bilaterally up to 4 times a day. randomization will then occur as 1:1 where patients will be assigned to receive huc3-053 or hyalein mini drops given bilaterally five to six times a day. the treatment period is 12 weeks.

Eligibility criteria:
inclusion criteria: * age over 19 * volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit. * corneal staining score(oxford grading) ≥ 2 and schirmer test ≤ 10mm/5min (if schirmer test = 0mm/5min, nasal stimulation schirmer test ≥ 3mm/5min) and tbut test ≤10 and osdi (ocular surface disease index) ≥ 23 in at least one of both eyes * best corrected visual acuity ≥ 0.2 in both eyes at screening and randomization visit exclusion criteria: * the patients with clinically significant ocular disorders affected the test result current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * sbp ≥140mmhg or dbp ≥ 90mmhg or hba1c\>9% * wearing contact lenses within 72 hr of screening visit * pregnancy or breastfeeding
pilot study to clinical evaluate device prototypes in dry eye patients

Conditions: Dry Eye Syndrome

Summary: the study will assess the safety, tolerability and feasibility of lacrima investigational medical device to treat dry eye patients


Eligibility criteria:
main inclusion criteria: 1. male or female, 18 years of age and over at screening 2. diagnosis of mild to moderate dry eye, as defined by: 1. positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the national eye institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; and 2. schirmer test score (with anesthesia, 5 minutes \< 5 mm either eye) ; and 3. osdi score of ≥12 and osdi score of \<33 main exclusion criteria: 1. persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start. 2. any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection 3. patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening 4. receipt of any type of topical artificial eye drops within 3 days prior to screening 5. receipt of topical cyclosporine eye drops within 3 months prior to screening

Keywords: keratoconjunctivitis sicca dry eye syndromes
bradycardia recognition and detection in young infants part-i

Conditions: Neonatal Bradycardia; Hypoxemia of Newborn

Summary: this prospective cohort study will determine the diagnostic accuracy of the owlet oss 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.

we will attach an owlet monitor to infants for a 48-hour period. we will prospectively collect data from this device to determine the accuracy of bradycardia and hypoxemia detection compared with hospital monitors. in addition, we will collect simultaneous high-resolution real time cardiorespiratory data from philips mp70 patient monitors at the university of alabama at birmingham.

Eligibility criteria:
inclusion criteria: * off ventilatory support/ncpap/hfnc and phototherapy for \> 48 hours * less than one-year corrected age * current weight \>1500 grams * parents/legal guardians have provided consent for enrollment exclusion criteria: * a major malformation * a neuromuscular condition that affects respiration or causes apnea * active skin breakdown or skin infection * terminal illness or decision to withhold or limit support * we will exclude data from infants who develop shock/sepsis or require ventilatory support or phototherapy during the study period.
to explore the feasibility of dynamic changes of tcr diversity in peripheral blood in monitoring recurrence and evaluating prognosis of epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer; Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Summary: this project proposes to elucidate the functional impact of t cells in cancer progression and treatment through a comprehensive tcr profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of tcr diversity with clinical outcomes and the potential role of tcr profiling in cancer prognosis.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients with advanced eoc, 18-75 years of age: including patients with preoperative assessment of stage iii-iv eoc, who underwent initial tumour cytoreduction and 6-8 courses of postoperative chemotherapy with paclitaxel + carboplatin/docetaxel + carboplatin; * eastern cooperative oncology group (ecog) physical strength status (ps) score of 0 or 1; * cooperation in the treatment process by providing clinicopathological data and imaging data required for the study process; * cooperate with follow-up visits and collection of node blood for clinical efficacy assessment, and agree to use the test data for subsequent research and product development. * the initial and follow-up treatment processes are in accordance with nccn guidelines; exclusion criteria: * neoadjuvant chemotherapy patients; * splenectomy patients; * patients with contraindications to radiotherapy; * any other patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study; * unacceptable or unavailable means of assessing specified efficacy such as imaging; * vaccination within 2 months; antibiotics for infection within 2 weeks; history of blood transfusion within 2 weeks; * long-term use of recombinant human erythropoietin, recombinant human interleukin, ricodin tablets and other drugs affecting the composition of blood cells; * severe organ dysfunction; * infectious diseases such as immunodeficiency syndrome, active tuberculosis, hiv infection, and other infectious diseases not suitable for participation; * pre-cancerous diseases of the blood, such as myelodysplastic syndromes; * have received immunosuppressive therapy within 2 weeks; * suffering from blood clotting disorders.

Keywords: tcr immunological monitoring
hpv prevalence in 16-20 year old males

Conditions: HPV Infection

Summary: in quebec, 18 birth cohorts of girls were vaccinated against hpv (aged 9 to 29 years in 2020). with an observed vaccination coverage of \>80% an important herd effect might be expected. this study aim is to measure the hpv types prevalence in unvaccinated sexually active boys aged 16 to 20 years.

an hpv immunization program is in place in quebec since 2008. by 2020 18 birth cohorts of girls were eligible for vaccination. vaccine uptake with at least one dose of vaccine was \>80%. with such a high vaccine uptake an important herd immunity might be expected. the main objective of this study is to measure the prevalence of different hpv types in unvaccinated sexually active boys aged 16 to 20 years. this is a cross sectional study which includes one visit for all participants. self sampling technic is used. during this phase of the study a total of 681 boys will be recruited. an additional phase of the study will be conducted at the condition that the prevalence of hpv6/11/16/18/31/33/45/52 and 58 in unvaccinated boys will be at least 8.65%. the second phase of the study if conducted will measure the prevalence of the same hpv types in 681 vaccinated boys of the same age.

Eligibility criteria:
inclusion criteria: * unvaccinated against hpv * sexually active exclusion criteria: * received an hpv vaccine * non sexually active

Keywords: prevalence boys
sleep behaviors in pregnancy

Conditions: Sleep; Pregnancy Complications

Summary: the researchers would like to know how long pregnant women spend in different positions during the night - and how often women change positions - across pregnancy. the researchers also want to see if the sleep monitor is able to improve sleep behaviors


Eligibility criteria:
inclusion criteria: * at least 28 weeks pregnant * receiving pre-natal care at michigan medicine * have either and android or iphone smartphone exclusion criteria: * less then 28 weeks pregnant * receiving pre-natal care external to michigan medicine * does not poses a smartphone
transcranial magnetic stimulation in stroke motor rehabilitation treatment

Conditions: Stroke

Summary: the goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rtms) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.

occlusion of the middle cerebral artery is the most common cause of stroke. because the middle cerebral artery supplies blood to the motor cortices, middle cerebral artery stroke often impacts the integrity of the motor cortex and its associated corticospinal projections. less than half of all individuals post-stroke regain complete motor function. because motor deficits, especially of the upper extremities, can dampen the quality of life, there is an urgent need to improve current rehabilitation programs to allow more stroke survivors to achieve higher functional gains. motor training is an important part of recovery after stroke. during motor training, patients practice performing a movement and become better at performing the trained movement over time. repetitive transcranial magnetic stimulation (rtms), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. there is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rtms for some stroke survivors. in the current study, the investigator will determine the effect of rtms over the premotor cortex on training-related improvements in motor performance in adults who experienced a stroke more than 6 months ago.

Eligibility criteria:
inclusion criteria: * have the ability to give informed, written consent * be aged 30-80 years old * have a single ischemic infarction affecting the primary motor system * have intact cognitive abilities * no current depression * no neurological disease * no contradictions to tms * no history of seizures or epilepsy * no implanted medical device * no metal in neck or head * no history of migraine headaches * no intake of medication that lowers seizure threshold exclusion criteria: * none

Keywords: transcranial magnetic stimulation neurophysiology neuroscience stroke rehabilitation
a registry for patients treated on the clinical trial tax 3503

Conditions: Prostate Cancer

Summary: the purpose of this study is to continue follow-up on patients who were treated on the study called tax 3505 (msk irb #07-101). the sponsor of this study, has decided to end the study early, before all patients have completed all planned follow-up tests. as a result, the investigators do not yet know whether hormonal therapy alone, or in combination with docetaxel, is better at preventing prostate cancer recurrence in patients who had a rising psa after prostatectomy. this study will continue following patients according to a schedule that is similar to that found in the tax 3503 (msk irb #07-101) study in order to answer that question. this study is known as a registry study. the patients' will not receive any treatment as part of this study. instead, they will be asked to have a blood test performed once every 12 weeks.


Eligibility criteria:
inclusion criteria: * the registry will include the database of all patients registered to tax3503. those patients who will be prospectively tracked through the registry are those who meet the following criteria: 1. the patient must have been registered to tax3503 2. the patient must not have met the definition of progression as defined in tax3503 while on tax3503 patients who have progressed or hit their 36 month post treatment date between the closure of tax3503 and the activation of this tax3503 registry protocol will be permitted on the study to capture their date of progression or their 36 month post treatment progression free date. exclusion criteria: * patients who were not registered to tax3503 are not eligible to have their data stored in this registry.

Keywords: tax 3503 mskcc irb#07-101 12-225
rivaroxaban for patients with antiphospholipid syndrome

Conditions: Antiphospholipid Syndrome

Summary: long-term anticoagulation is widely used for secondary thromboprophylaxis in the antiphospholipid syndrome (aps) due to the high risk of recurrent events. currently anticoagulation with vitamin k antagonists (vkas) is the standard of care but have unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment. rivaroxaban, an orally active direct factor xa inhibitor, has been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism and non valvular atrial fibrillation in major rcts. no studies had been published in aps.the aim of the study is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis in patients with aps compared with acenocoumarol

this is a phase 3 randomized, multicenter, non-inferiority open-label rct. 190 eligible aps patients with arterial or venous thrombotic history receiving acenocoumarol will be stratified according the presence of sle and venous/arterial thrombotic history and randomized (1:1) either to continue vitamin k antagonists (standard of care, normalized ratio (inr) 2-3 or 2.5 to 3.5 in those with recurrent thrombotic episodes) or to switch to rivaroxaban (20 mg/day). the primary efficacy outcome is the development of any thrombotic event during the study period. secondary efficacy outcomes include time to thrombosis, type of thrombosis (arterial or venous), overall causes of death, evaluation of a prognostic biomarker panel of recurrent thrombosis. the primary safety outcome will be major bleeding. secondary safety outcomes include any adverse event and minor bleeding.

Eligibility criteria:
inclusion criteria: * patients with thrombotic antiphsopholipd syndrome * treated with acenocumarol for a minimum period of 6 months * positivity for lupus anticoagulant and/or anti-cardiolipin or anti-b2gpi antibodies igg or igm≥40 exclusion criteria: * major haemorrhage (cerebral or gastrointestinal) within the previous 6 months * neurosurgery within the previous 4 weeks * any surgery within the previous 10 days * active peptic ulcus * alt or gpt \>120 ui/ml non-lupus related in the previous 30 days * platelets \<30x10e9 in the previous 30 days * recent diagnosed malignancy * any criteria listed in the summary of the produt characterisitcs (spc) * renal disease with a creatinine clearance \<30 ml/min or with a known uncontrolled renal disease * concomitant administration of drugs that could interfere with cyp3a4